COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49864

Qingling Zhang

zqling68@hotmail.com

2020-02-22

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

Suspected cases of neo-coronary pneumonia (outside Hubei province), clinically diagnosed cases (in Hubei province), and light / general confirmed cases, severe/critical confirmed cases, aged 18-70 years, each center enrolls cases in a competitive manner. The diagnostic criteria for the new coronavirus pneumonia conform to the diagnostic criteria issued by the National Health and Medical Commission for the diagnosis and treatment of pneumonia in the new coronavirus infection (trial version 5): (1) Suspected cases. Comprehensively analyze combinations of the following epidemiological history and clinical presentations: 1.1.1.Epidemiological history (1) Within 14 days prior to onset, had history of travel or residence in Wuhan or surrounding regions, or other communities reporting cases, (2) Within 14 days prior to symptom onset, having had contact with patients infected with 2019-nCoV (positive nucleic acid test). (3) Within 14 days prior to onset, had contact with patients who had a fever or respiratory tract symptoms that had come from Wuhan, its surrounding regions, or other communities reporting cases. (4) Clustered onset (Within a span of 2 weeks, 2 or more cases with fever and/or respiratory symptoms appear in a small area, such as a family, an office, or a school class) 2. Clinical presentations (1) Fever and/or respiratory tract symptoms, (2) Having the imaging features of novel coronavirus pneumonia discussed above, (3) During the early stages of the disease, white blood cell count is normal or reduced, while the lymphocyte count is normal or reduced. Where there are any of the epidemiologic history items, and any 2 of the clinical presentions are met. Where there is no clear epidemiological history, and at least 3 of the clinical presentations are met. (2) Confirmed cases. A 2019-nCoV diagnosis is confirmed if the suspected cases also have one of the following etiological or serological evidence. 1.1.Positive result in real-time fluorescence RT-PCR detection of novel coronavirus nucleic acid, 2.The sequence of the virus is highly homologues to that of 2019-nCoV. 3.Specific IgM and IgG antibodies against 2019-nCoV test positive in the serum, IgG antibodies specific to 2019-nCoV test positive after previous negative results, or increased by more than 4 times in the recovery phase compared to the acute phase. VI. Clinical classifications (1) Mild form. Clinical symptoms are minor, imaging does not show signs of lung inflammation. (2) Regular form. Has fever and respiratory tract symptoms, imaging shows visible lung inflammation. (3) Severe form. Adults who meet any one of the following: 1.1.Shortness of breath, RR > 30 breaths/minute, 2. Oxygen saturation < 93% at rest 2.Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa). For high altitude (altitude over 1000 meters) regions, (PaO2/FiO2) should be corrected according to the following formula: PaO2/FiO2 x [ atmospheric pressure (mmHg)/760] The patient should be managed as a severe case if lung imaging shows a substantial progression of lesions (greater than 50%) within 24-48 hours. Children who meet any one of the following: 1. Show shortness of breath (< 2 months old, RR> 60 times/min, 2~12 months old, RR>50 times/min, 1~5 years old, RR>40 times/min, 55 years old, RR>0 times/min), except the effects of fever and crying, 2. Oxygen saturation < 92% at rest. 3. Laboured breathing (wheezing, flaring o

1. Patients with presence, coagulopathy or hypotension, 2. Pregnant and lactating women, 3. People with allergies or allergies to Xuebijing Injection and its components, 4. Severe basic diseases that affect survival, including: uncontrolled malignant tumors that have metastasized and cannot be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc., 5. Pulmonary tumors caused by obstructive pneumonia, severe interstitial fibrosis, alveolar proteinosis, allergic alveolitis, 6. Continued use of immunosuppressive agents or organ transplants in the last 6 months, 7. Extracorporeal life support (ECMO, ECCO2R, RRT), 8. Expected deaths within 48 hours, 9. Clinicians judge inappropriate.

2

The First Affiliated Hospital of Guangzhou Medical University

18

70

China

No restriction on type of patients

0: No restriction on type of patients

460

Complete Blood Count;CRP;blood coagulation;D-dimer;Virological examination of pharyngeal swab;Pulmonary imaging;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

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